According to Insmed, the company has filed an MAA for its Arikayce liposomal amikacin for inhalation, and it has been informed by the EMA that the only remaining issue, a review of the Pediatric Investigation Plan (PIP) by the agency’s Pediatric Committee, should be finished by the first quarter of 2015.
A trial of Arikayce for the treatment of resistant nontuberculous mycobacteria (NTM) lung infections “is on track,” the company said, and screening of patients is expected to begin by the end of January 2015. In October 2014, Insmed announced that it was moving ahead with two Phase 3 studies of Arikayce for that indication.
In addition to the updates on Arikayce, the company also announced that it has completed an IND meeting with the FDA for its INS-1009 inhaled treprostinil for the treatment of pulmonary arterial hypertension (PAH). Insmed said that it has confirmed that “subject to final review of the pre-clinical data,” the product “would be eligible for a 505(b)(2) approval pathway.”
Read the Insmed press release.
